跳至主要内容
临床试验/NCT07506642
NCT07506642已完成不适用

Patient-Reported Experience Measures Of EUS-Guided Versus Percutaneous Liver Biopsy: A Prospective Randomized Controlled Study

University Hospital Muenster1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2023年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
102
试验地点
1
主要终点
Patient reported experience measure

研究概览

简要总结

Patient Experience in Endohepatology Liver biopsy is a crucial procedure for the diagnosis and/or staging of liver diseases. Common indications for non-targeted biopsies include unexplained elevated liver function tests (LFTs), guiding medical therapy in autoimmune liver diseases or following liver transplantation (LT), and prognostic assessment in ambiguous clinical situations, occasionally within the scope of research.

Traditionally, there are three primary routes for obtaining liver biopsies: Percutaneous liver biopsy (PC-LB), transjugular (and thus endovascular) liver biopsy (TJ-LB), and surgical (mostly laparoscopic) approaches (LAP-LB). In recent years, endoscopic ultrasound-guided liver biopsy (EUS-LB) has gained significant importance as an alternative procedure. Technically, this approach usually involves puncturing the left liver lobe transgastrically using a 19G needle; however, the right liver lobe can also be targeted transduodenally. Regarding technical feasibility and cost-effectiveness, several studies report non-inferiority or even superiority compared to the standard percutaneous procedure.

Modern medicine increasingly recognizes that patient experience is a critical indicator of healthcare quality. While patient experience was mostly neglected in the past-aside from measuring the occurrence of pain-the modern definition encompasses the entire experience within the healthcare system, including social, somatic and organizational aspects. Consequently, this quality indicator is now assessed using validated questionnaires known as Patient-Reported Experience Measures (PREMs). The Newcastle-ENDOPREM was specifically developed and validated for the evaluation of endoscopic procedures.

Since EUS-LB and PC-LB perform similarly regarding technical aspects and safety, the question arises as to which method achieves higher patient satisfaction. This is particularly relevant as PC-LB is considered an unpleasant procedure that must frequently be repeated in patients with chronic liver diseases to guide medical therapy.

To the best of our knowledge, no direct head-to-head comparison between EUS-LB and PC-LB regarding patient experience has been conducted to date. Therefore, the aim of this study is to compare these two methods in terms of patient satisfaction with the procedure, using a modified version of the Newcastle-ENDOPREM.

  1. Current State of Science At the time of planning the implementation of endoscopic ultrasound-guided liver biopsy into the routine of Medical Clinic B, only one randomized controlled trial by Bang et al. exists comparing pain perception between the two procedures. This study indicates that percutaneous liver biopsy is more painful. The sample size calculation was performed according to the results of this study.
  2. Study Objectives The objective of the study is to measure the patient experience during liver biopsies and to identify the procedure that is better tolerated by patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age above 18 years
  • Clinical indication for untargeted liver biopsy
  • Written informed consent

排除标准

  • Presence of ascites
  • Severe coagulopathy (INR > 2, platelet count < 50x10^3/µl)
  • Contraindication to undergo endoscopy or sedation
  • Anatomical alterations that impede liver biopsy (e.g. Chilaiditi syndrome)
  • Pregnancy

研究组 & 干预措施

Percuteaneous Liver Biopsy

干预措施: Percutaneous Liver Biopsy (Procedure)

EUS-Guided Liver Biopsy

干预措施: EUS Liver Biopsy (Procedure)

结局指标

主要结局

Patient reported experience measure

时间窗: Questionnaires are filled out immediately after the procedure once the patient is conscious enough to fill out the questionnaire.

Questionnaire for measuring patient experience. The questionnaire is based on the Newcastle ENDOPREM published by Neilson et al.. The modified PREM comprises six domains including completion of the PREM, referral, feelings before, during and after the procedure and overall experience. Most of the questions are likert-scaled (scaled from strongly aggree to strongly disaggree in five categories), few are categorical or visual analogue scaled. Every item has it's own scale regarding good or bad outcome. Items are analyzed independently.

次要结局

未报告次要终点

研究者

发起方
University Hospital Muenster
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Michael Praktiknjo

Professor of hepatology

University Hospital Muenster

研究点 (1)

Loading locations...

相似试验